Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 617-116-8 | CAS number: 80573-04-2
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No guideline is specified in the report.
- GLP compliance:
- no
Test material
- Reference substance name:
- Benzoic acid, 5-[(1E)-[4-[[(2-carboxyethyl)amino]carbonyl]phenyl]azo]-2- hydroxy-, disodium salt, dihydrate
- Cas Number:
- 150399-21-6
- Molecular formula:
- C17H13N3O6Na2 . 2H2O
- IUPAC Name:
- Benzoic acid, 5-[(1E)-[4-[[(2-carboxyethyl)amino]carbonyl]phenyl]azo]-2- hydroxy-, disodium salt, dihydrate
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Biorex
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 3, 12 and 27 weeks
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 500 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- 5 male animals per dose were used for the fertility test after 3, 12 and 27 weeks of treatment.
- Control animals:
- yes, plain diet
- Details on study design:
- The test was performed by mating each male with 5 females of proven fertility for 4 days then females were killed 14 days later.
Examinations
- Postmortem examinations (parental animals):
- SACRIFICE
- Maternal animals: All females were sacrificed 14 days after mating.
GROSS NECROPSY
- The number of pregnant females, corpora lutea, live/ dead foetuses and early/ late resorptions were recorded.
Results and discussion
Results: P0 (first parental generation)
Reproductive function / performance (P0)
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- Male fertility was not affected by the treatment
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day
- Sex:
- male
- Basis for effect level:
- reproductive performance
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: P1 (second parental generation)
Effect levels (P1)
- Remarks on result:
- not measured/tested
Results: F1 generation
Effect levels (F1)
- Remarks on result:
- not measured/tested
Results: F2 generation
Effect levels (F2)
- Remarks on result:
- not measured/tested
Overall reproductive toxicity
- Reproductive effects observed:
- no
Any other information on results incl. tables
For general toxicity results, please refer to IUCLID Section 7.5.1 (96 week study).
Applicant's summary and conclusion
- Conclusions:
- No treatment related effects on male fertility were observed up to the highest dose tested.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
